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Clinical trial

The Effect of Two Different Anesthetic Methods on Gastrointestinal Motility in Patients Scheduled for Laparoscopic Sleeve Gastrectomy: a Prospective, Randomized, Single Blinded Clinical Trial

ID
Name
HandeBariatric
Description
The goal of this randomized controlled single blinded study is to compare the effect of the type of anesthesia on gastrointestinal motility in patients scheduled for laparoscopic sleeve gastrectomy. The main question it aims to answer is how do inhalation anesthesia and total intravenous anesthesia effect the gastrointestinal peristalsis during anastomosis. Participants will be American Society of Anesthesiology (ASA) physical status II and III, between 18- 60 ages. Researchers will compare inhalation anesthesia where desflurane is used with total intravenous anesthesia to see if the gastrointestinal motility differs between the groups.
Trial arms
Trial start
2022-08-15
Estimated PCD
2023-08-15
Trial end
2023-12-31
Status
Recruiting
Treatment
Desflurane
In inhalation group, desflurane will be used for general anesthesia maintenance under the screening with Patient State Index (PSI) between a score of 25-50. Remifentanil infusion is used with desflurane with a dose of 0.05-2 mcg/ kg/ min according to PSI . Fresh gas flow is used 2 L/ min with a mixture of 50%- 50% oxygen and medical air in both groups.
Arms:
Group inhalation
Other names:
suprane
Remifentanil infusion
Remifentanil infusion will be used with a dose of 0.05-2 mcg/ kg/ min under the screening with Patient State Index (PSI) between a score of 25-50 in both groups.
Arms:
Group inhalation, Group tiva
Other names:
ultiva
Fresh gas
Fresh gas flow will be used 2 L/ min with a mixture of 50%- 50% oxygen and medical air in both groups.
Arms:
Group inhalation, Group tiva
Propofol infusion
Propofol infusion will be used for general anesthesia maintenance with a dose of under the screening of Patient State Index (PSI) between a score of 25-50 in group tiva.
Arms:
Group tiva
Other names:
propofol 2%
Size
60
Primary endpoint
Gastrointestinal motility
during surgery
Eligibility criteria
Inclusion Criteria: * 18-60 ages * ASA II-III * Patients scheduled for elective laparoscopic sleeve gastrectomy * Body mass index 35 kg m2 and over Exclusion Criteria: * Hepatic disease * Kidney disease * Congestive heart disease * Diabetes mellitus * Neurological deficit * Psychiatric disease * Pregnancy * Delayed gastric empting * Previous bariatric surgery * Patient's refusal * Open surgery
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-07-19

1 organization

3 products

2 indications

Organization
Bozyaka Training and Research Hospital
Product
Desflurane
Indication
Anesthesia
Indication
Total Intravenous Anesthesia
Product
Remifentanil
Product
Propofol